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NCT00296504 · ClinicalTrials.gov registry record · Phase 3
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
A Phase 3 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 753
- Enrollment target
- 20
- Study locations
NCT00296504: Completed Phase 3 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
NCT00296504 is a Phase 3 study of Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 753 participants, above the 108-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (597% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00296504, a Phase 3 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 753 participants
- Enrollment target
- 20
- Study locations
Study Summary
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Conditions Studied
Interventions
- DRUG ritonavir
- DRUG fosamprenavir (GW433908)
Study Locations (20)
Other
- GSK Investigational Site - Le Kremlin-Bicêtre
- GSK Investigational Site - Marseille
- GSK Investigational Site - Paris
- GSK Investigational Site - Paris
- GSK Investigational Site - Vandœuvre-lès-Nancy
- GSK Investigational Site - Villejuif
- GSK Investigational Site - Coimbra
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Orlando
- GSK Investigational Site - Orlando
- GSK Investigational Site - Sarasota
- GSK Investigational Site - Tampa
California
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - San Francisco
Colorado
- GSK Investigational Site - Denver
New York
- GSK Investigational Site - Manhasset
Texas
- GSK Investigational Site - Galveston
São Paulo
- GSK Investigational Site - Campinas
Región Metro de Santiago
- GSK Investigational Site - Santiago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 753 participants |
| Start Date | 2001-11 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00296504 record still lists
NCT00296504 is an interventional study that assigns participants to a tested intervention. The registered 753 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (597% higher).
The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 2 interventions - of which ritonavir is the first listed.
NCT00296504 names 20 study sites across 9 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT00296504 about?
NCT00296504 is a clinical study titled "A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects". GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safe...
What is the current status of trial NCT00296504?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 753 participants. The study started on 2001-11. Estimated completion is 2010-10.
What conditions does trial NCT00296504 study?
This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT00296504?
The interventions under investigation include: ritonavir (DRUG), fosamprenavir (GW433908) (DRUG).
Who is sponsoring clinical trial NCT00296504?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00296504 being conducted?
This trial has 20 study locations across California, Colorado, Florida, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00296504's enrollment target sits among peer trials
753 1st of 19 higher than 19 of 19 other Infection, Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infection, Human Immunodeficiency Virus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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